Protective Role of Vitamin D in Breast Cancer Patients Treated With Doxorubicin

• Status: Completed
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study is aimed at Evaluation of the potential protective effect of Vitamin D in doxorubucin- induced toxicity in breast cancer patients.

Proposal Steps:

1. 100 Patients recruited from Alexandria Main University Hospital (AMUH), Oncology Unit are randomly assigned in to two groups:

• Control group (n=50) the patient will receive AC regimen (Doxorubucin & cyclophosphamide) for 4 cycles every 21 day (i.e. 3 months.)

• Vitamin D group (n=50) who will receive 4 Cycles AC regimen in addition to vitamin D (Bon One 0.5 microgram®) once daily.

2. Echocardiography (Echo) will be done at base line and at the end of the treatment.

3. Vitamin D, LDH, Troponin-t as well as IL-6 will be assessed at baseline and at the end of the study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Damanhour University
• Treatments: Alfacalcidol; Doxorubicin; Ergocalciferols; Hydroxycholecalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Patients has a good performance status (ECOG 0-2) according to eastern cooperative oncology group (ECOG) score.

• Adequate complete blood picture patients.

• Females from (30-65) years of old.

• Normal renal and liver functions.

Exclusion criteria:

• Cardiac diseased or reduced cardiac output with left ventricular ejection fraction less than 50%.

• Hepatic impaired patients.

• Pregnancy or breast feeding or child bearing state.

• Patient with history of allergy to vitamin D.

• Concomitant use of other vitamins.

• Renal impaired patients.

• History of breast cancer.